Acetaminophen and Salicylates (Systemic)

Before Using This Medicine

If you are taking this medicine without a prescription, carefully read and follow any precautions on the label. For acetaminophen and salicylate combinations, the following should be considered:

Allergies - Tell your doctor if you have ever had any unusual or allergic reaction to acetaminophen, aspirin or other salicylates including methyl salicylate (oil of wintergreen), or to any of the following medicines:

• Diclofenac (e.g., Voltaren)
• Diflunisal (e.g., Dolobid)
• Etodolac (e.g., Lodine)
• Fenoprofen (e.g., Nalfon)
• Floctafenine (e.g., Idarac)
• Flurbiprofen, oral (e.g., Ansaid)
• Ibuprofen (e.g., Motrin)
• Indomethacin (e.g., Indocin)
• Ketoprofen (e.g., Orudis)
• Ketorolac (e.g., Toradol)
• Meclofenamate (e.g., Meclomen)
• Mefenamic acid (e.g., Ponstel)
• Nabumetone (e.g., Relafen)
• Naproxen (e.g., Naprosyn)
• Oxaprozin (e.g., Daypro)
• Phenylbutazone (e.g., Butazolidin)
• Piroxicam (e.g., Feldene)
• Sulindac (e.g., Clinoril)
• Tenoxicam (e.g., Mobiflex)
• Tiaprofenic acid (e.g., Surgam)
• Tolmetin (e.g., Tolectin)

Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy -

• For acetaminophen : Studies on birth defects have not been done in humans. However, acetaminophen has not been reported to cause birth defects or other problems.
• For aspirin : Studies in humans have not shown that aspirin causes birth defects. However, aspirin has been shown to cause birth defects in animals.
  Do not take aspirin during the last 3 months of pregnancy unless it has been ordered by your doctor . Some reports have suggested that too much use of aspirin late in pregnancy may cause a decrease in the newborn's weight and possible death of the fetus or newborn infant. However, the mothers in these reports had been taking much larger amounts of aspirin than are usually recommended. Studies of mothers taking aspirin in the doses that are usually recommended did not show these unwanted effects. However, there is a chance that regular use of aspirin late in pregnancy may cause unwanted effects on the heart or blood flow in the fetus or newborn infant.
  Use of aspirin during the last 2 weeks of pregnancy may cause bleeding problems in the fetus before or during delivery, or in the newborn infant. Also, too much use of aspirin during the last 3 months of pregnancy may increase the length of pregnancy, prolong labor, cause other problems during delivery, or cause severe bleeding in the mother before, during, or after delivery.
• For salicylamide : Studies on birth defects have not been done in humans.
• For caffeine : Studies in humans have not shown that caffeine causes birth defects. However, use of large amounts of caffeine by the mother during pregnancy may cause problems with the heart rhythm of the fetus and may affect the growth of the fetus. Studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to the amount of caffeine in 12 to 24 cups of coffee a day).

Breast-feeding -

• For acetaminophen and for aspirin : Acetaminophen and aspirin pass into breast milk; however, they have not been reported to cause problems in nursing babies.
• For caffeine : Caffeine (contained in some of these combination medicines) passes into breast milk in small amounts. Taking caffeine in the amounts present in these medicines has not been reported to cause problems in nursing babies. However, studies have shown that babies may appear jittery and have trouble in sleeping when their mothers drink large amounts of caffeine-containing beverages. Therefore, breast-feeding mothers who use these medicines probably should limit the amount of caffeine they take in from other medicines or from beverages.

Children -

• For acetaminophen : Acetaminophen has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.
• For aspirin and for salicylamide : Do not give a medicine containing aspirin or salicylamide to a child with symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child's doctor . This is very important because aspirin may cause a serious illness called Reye's syndrome in children with fever caused by a virus infection, especially flu or chickenpox. Children who do not have a virus infection may also be more sensitive to the effects of aspirin, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating. This may increase the chance of side effects during treatment.
• For caffeine : There is no specific information comparing use of caffeine in children younger than 12 years of age with use in other age groups. However, caffeine is not expected to cause different side effects or problems in children than it does in adults.

Adolescents - Teenagers with fever or other symptoms of a virus infection, especially flu or chickenpox, should check with a doctor before taking a medicine containing aspirin or salicylamide . Aspirin and salicylamide may cause a serious illness called Reye's syndrome in teenagers with fever caused by a virus infection, especially flu or chickenpox.

Older adults - Elderly people may be more likely than younger adults to develop serious kidney problems if they take large amounts of these combination medicines for a long time. Therefore, it is best that elderly people not take this medicine for more than 5 days in a row unless they are under a doctor's care.

• For acetaminophen : Acetaminophen has been tested and, in effective doses, has not been shown to cause different side effects or problems in older people than it does in younger adults.
• For aspirin : People 60 years of age and older are especially sensitive to the effects of aspirin. This may increase the chance of side effects during treatment.
• For caffeine : Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of caffeine in the elderly with use in other age groups.

Other medicines - Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking an acetaminophen and salicylate combination, it is especially important that your health care professional know if you are taking any of the following:

• Anticoagulants (blood thinners) or
• Carbenicillin by injection (e.g., Geopen) or
• Cefamandole (e.g., Mandol) or
• Cefoperazone (e.g., Cefobid) or
• Cefotetan (e.g., Cefotan) or
• Dipyridamole (e.g., Persantine) or
• Divalproex (e.g., Depakote) or
• Heparin or
• Inflammation or pain medicine, except narcotics, or
• Pentoxifylline (e.g., Trental) or
• Plicamycin (e.g., Mithracin) or
• Ticarcillin (e.g., Ticar) or
• Valproic acid (e.g., Depakene) - Taking these medicines together with aspirin (present in some of these combination medicines) may increase the chance of serious bleeding

• Antidiabetics, oral (diabetes medicine you take by mouth) - Aspirin (present in some of these combination medicines) may increase the effects of the antidiabetic medicine; a change in dose may be needed if aspirin is taken regularly

• Ciprofloxacin (e.g., Cipro) or
• Enoxacin (e.g., Penetrex) or
• Itraconazole (e.g., Sporanox) or
• Ketoconazole (e.g., Nizoral) or
• Lomefloxacin (e.g., Maxaquin) or
• Norfloxacin (e.g., Noroxin) or
• Ofloxacin (e.g., Floxin) or
• Tetracyclines (medicine for infection), taken by mouth - Antacids (present in buffered forms of acetaminophen and salicylate combination medicines) can keep these other medicines from working properly if the medicines are taken too closely together

• Methotrexate (e.g., Mexate) - Taking aspirin (present in some of these combination medicines) together with methotrexate may increase the chance of serious side effects

• Probenecid (e.g., Benemid) - Aspirin (present in some of these combination medicines) can keep probenecid from working properly for treating gout

• Sulfinpyrazone (e.g., Anturane) - Aspirin (present in some of these combination medicines) can keep sulfinpyrazone from working properly for treating gout; also, taking aspirin together with sulfinpyrazone may increase the chance of bleeding

• Urinary alkalizers (medicine that makes the urine less acid, such as acetazolamide [e.g., Diamox], calcium- and/or magnesium-containing antacids, dichlorphenamide [e.g., Daranide], methazolamide [e.g., Neptazane], potassium or sodium citrate and/or citric acid, sodium bicarbonate [baking soda]) - These medicines may make aspirin (present in some of these combination medicines) less effective by causing it to be removed from the body more quickly

Other medical problems - The presence of other medical problems may affect the use of acetaminophen and salicylate combinations. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse or
• Asthma, allergies, and nasal polyps (history of) or
• Hepatitis or other liver disease or
• Kidney disease - The chance of serious side effects may be increased

• Anemia or
• Stomach ulcer or other stomach problems - Aspirin (present in some of these combination medicines) may make these conditions worse

• Gout - Aspirin (present in some of these combination medicines) can make this condition worse and can also lessen the effects of some medicines used to treat gout

• Heart disease - Caffeine (present in some of these combination medicines) can make your condition worse

• Hemophilia or other bleeding problems - Aspirin (present in some of these combination medicines) increases the chance of serious bleeding